LEXINGTON, MA, USA I January 21, 2020 I Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient into the Phase 3 INVIGORATE Trial of topical ocular reproxalap in patients with allergic conjunctivitis.
“Initiating enrollment in the INVIGORATE Trial moves us closer to our goal of providing allergic conjunctivitis patients with a new treatment option for one of the world’s most common ocular conditions,” said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Standard of care antihistamines are ineffective in nearly a quarter of all allergic conjunctivitis patients, many of whom require adjunct therapy, including corticosteroids, which cannot be used chronically due to toxicity. We believe that reproxalap may offer a durable and highly differentiated approach for the treatment of ocular allergy, a condition that is increasing in prevalence but has not benefited from the introduction of a novel therapeutic approach in decades.”
The INVIGORATE Trial, which will enroll approximately 120 patients, is a randomized, double-masked, crossover vehicle-controlled Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score.
In Aldeyra’s Phase 2 allergen chamber clinical methods trial, completed in March 2019, 0.25% reproxalap demonstrated highly statistically significant reductions from vehicle in ocular itching and redness.
More information about the INVIGORATE Trial is available on www.clinicaltrials.gov (NCT04207736).
About Reproxalap
Reproxalap is a novel, small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease, and lead to activation of intracellular inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.
About Allergic Conjunctivitis
Allergic conjunctivitis affects more than 1 billion people worldwide,1 including more than 100 million in the U.S.2 The disease is thought to be mediated in part by RASP. The signs and symptoms of allergic conjunctivitis – ocular itching, redness, and tearing – are persistently disturbing, affecting quality of life and leading to loss of work that can create a substantial economic burden for patients and families.3 Allergic conjunctivitis is hyperendemic and prevalence is increasing. Although allergic conjunctivitis is one of the most common diseases treated by ophthalmologists and optometrists, in many cases physicians and patients report that currently available therapy is inadequate. Today, nearly one in five allergic conjunctivitis patients requires corticosteroids or other adjunctive therapy in addition to antihistamines.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, proliferative vitreoretinopathy, and Sjögren-Larsson Syndrome. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
1 White Book on Allergy (2013 Update)
2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy ClinImmunol.2010;126(4):778-783.e6
3 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J. Bron (2004) Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437
SOURCE: Aldeyra
Post Views: 58
LEXINGTON, MA, USA I January 21, 2020 I Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient into the Phase 3 INVIGORATE Trial of topical ocular reproxalap in patients with allergic conjunctivitis.
“Initiating enrollment in the INVIGORATE Trial moves us closer to our goal of providing allergic conjunctivitis patients with a new treatment option for one of the world’s most common ocular conditions,” said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Standard of care antihistamines are ineffective in nearly a quarter of all allergic conjunctivitis patients, many of whom require adjunct therapy, including corticosteroids, which cannot be used chronically due to toxicity. We believe that reproxalap may offer a durable and highly differentiated approach for the treatment of ocular allergy, a condition that is increasing in prevalence but has not benefited from the introduction of a novel therapeutic approach in decades.”
The INVIGORATE Trial, which will enroll approximately 120 patients, is a randomized, double-masked, crossover vehicle-controlled Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score.
In Aldeyra’s Phase 2 allergen chamber clinical methods trial, completed in March 2019, 0.25% reproxalap demonstrated highly statistically significant reductions from vehicle in ocular itching and redness.
More information about the INVIGORATE Trial is available on www.clinicaltrials.gov (NCT04207736).
About Reproxalap
Reproxalap is a novel, small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease, and lead to activation of intracellular inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications.
About Allergic Conjunctivitis
Allergic conjunctivitis affects more than 1 billion people worldwide,1 including more than 100 million in the U.S.2 The disease is thought to be mediated in part by RASP. The signs and symptoms of allergic conjunctivitis – ocular itching, redness, and tearing – are persistently disturbing, affecting quality of life and leading to loss of work that can create a substantial economic burden for patients and families.3 Allergic conjunctivitis is hyperendemic and prevalence is increasing. Although allergic conjunctivitis is one of the most common diseases treated by ophthalmologists and optometrists, in many cases physicians and patients report that currently available therapy is inadequate. Today, nearly one in five allergic conjunctivitis patients requires corticosteroids or other adjunctive therapy in addition to antihistamines.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead investigational drug product candidates are potential first-in-class treatments in development for dry eye disease, allergic conjunctivitis, proliferative vitreoretinopathy, and Sjögren-Larsson Syndrome. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
1 White Book on Allergy (2013 Update)
2 Singh K, Axelrod S, Bielory L. The epidemiology of ocular and nasal allergy in the United States, 1988-1994. J Allergy ClinImmunol.2010;126(4):778-783.e6
3 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony J. Bron (2004) Economic and quality-of-life impact of seasonal allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI: 10.1076/opep.11.1.17.26437
SOURCE: Aldeyra
Post Views: 58
